A Research Study for Latina Women With Breast Cancer

An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer

The purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects.

The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period.

All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Adherence, Medication; Cancer, Breast; Cancer-related Problem/Condition; Hormone Dependent Neoplasms
• Intervention / Treatment: Behavioral: "My Guide" (psychoeducation & self-management program)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female
• Diagnosis of breast cancer, non-metastatic, stage 0-III (A, B, or C)
• Receiving or received endocrine/hormone therapy within the last 3 years (36 months)
• At least 18 years of age
• Able to speak and read English or Spanish
• Able to provide informed consent
• Self-identify Hispanic/Latina ethnicity

Exclusion Criteria:

• Stage IV or metastatic
• Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
• Diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnoses for which participation in this trial is either inappropriate or dangerous - this includes patients who have a life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
• Illicit substance or alcohol dependence
• Suicidal ideation, plan, intent
• Alzheimer's, dementia, or history of stroke
• Scheduled reconstruction surgery within 1 month of any study procedures or involvement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "My Guide" (psychoeducation & self management program); Smartphone-based program plus standard clinical care.	Behavioral: "My Guide" (psychoeducation & self-management program); 12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of My Guide: Usefulness	To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.	T3 (immediately following 12 week intervention)
Acceptability of My Guide: Satisfaction	To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.	T3 (immediately following 12 week intervention)
Acceptability of My Guide: Learnability	To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.	T3 (immediately following 12 week intervention)
Acceptability of My Guide: Usability	To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.	T3 (immediately following 12 week intervention)
Demand of My Guide: Recruitment Rate	We assess demand of the My Guide application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, an 70% recruitment rate is considered an adequate level of demand.	12 weeks
Demand of My Guide: Retention Rate	Another way we assess demand of the My Guide application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, an 70% retention rate is considered an adequate level of demand.	12 weeks
Participant use of My Guide: Number of Login's	We assess participant use of the My Guide application by examining the number of participant logins to the web-based application.	12 weeks
Participant use of My Guide: Duration of Usage	We assess participant use of the My Guide application by examining the duration participant time spent on the website. Based on previous psychosocial and behavioral studies in oncology, an average of 8 hours of use is considered an adequate level of engagement.	12 weeks
Participant use of My Guide: Content Accessed	We assess participant use of the My Guide application by examining the type of content accessed by participants on the website.	12 weeks
Change in Medication adherence will be assessed primarily with the Adherence to Refills and Medication Scale (ARMS).	The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.	T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)	The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers and serves as a health-related quality of life (HRQoL) measure.	T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Change in Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms	The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects.	T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Neoplasms, Hormone-Dependent
• Other Study ID Numbers: STU00201961B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No